GMPs

Jul 28, 2017
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Jul 25, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jul 18, 2017
By Pharmaceutical Technology Editors
The agency cited the Italian company for aseptic processing failures.
Jul 12, 2017
By Pharmaceutical Technology Editors
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
Jul 12, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Jul 10, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 05, 2017
By Pharmaceutical Technology Editors
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
Jul 02, 2017
Pharmaceutical Technology
The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
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